Model Number 377177 |
Device Problems
Intermittent Capture (1080); Pacing Intermittently (1443); Ambient Noise Problem (2877)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2022 |
Event Type
malfunction
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Event Description
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This lead was explanted due to bipolar rv lead failure, with low out of range impedance on home monitoring the morning after implant.With bipolar programming the rv impedance measured less than 100 ohms, capture was intermittent at 7.5 v at 1.0 ms, and there was no sensing.Testing in unipolar revealed no issues and so the lead was permanently programmed to unipolar pacing and sensing, but noise was present which resulted in underpacing.At (b)(6) 2023 revision, bipolar impedance did normalize after suture tie downs were removed, but the decision was made to replace the lead anyway due to the noise.
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Manufacturer Narrative
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Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual, mechanical and electrical inspection.The analysis showed that the lead body was found squeezed and damaged 9.5 cm distal to the is-1 connector pin, which is assumed to be the root cause of the reported electrical issues.The damage most likely resulted from a tight suture sleeve during the implantation procedure.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.
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Search Alerts/Recalls
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